Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance

Hypoxia Clinical Trial

Official title:

Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498563
• Other study ID #: IRB#2006024
• Status: Completed
• Phase: N/A
• First received: July 9, 2007
• Last updated: April 22, 2015
• Start date: October 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2015
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy

• age 30 to 60 years

Exclusion Criteria:

• sleep disorders or abnormal sleep patterns

• mood or psychiatric disorders including claustrophobia

• altitude exposure above 5,000 ft in the previous 2 months

• born or raised at terrestrial altitude 5,000 ft or greater

• conditions that would disqualify for FAA Medical Certificate

• acute medical conditions

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Altitude
• Dyssomnias
• Environmental Sleep Disorder
• Hypoxia
• Parasomnias
• Sleep Disorders

Intervention

Procedure:
• altitude exposure in hypobaric chamber

Locations

Country	Name	City	State
United States	Oklahoma State University Center for Aerospace & Hyperbaric Medicine	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	The Boeing Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM)		7 hours; 4 hours
Secondary	Mood State measured by Profile of Mood States (POMS) Symptoms of altitude illness measured by Environmental Symptoms Questionnaire (ESQ IV) and Lake Louise Symptom Scores (LLS)		20 hours